• A Wave of High-Profile Court Cases Has Major Impact on the BioPharmaceutical Industry

    February 3, 2015

    While the biotech and pharmaceutical industries face ever-increasing intense global competition, there have been numerous, recent, high-profile litigation cases affecting the industry. Consequently, there is ever-increasing pressure on the industry to comply with these new legal mandates. This article provides the author’s thoughts regarding several high-profile litigation cases that are having a major impact on these industries.

    Truthful, Non-Misleading Off-Label Promotion of FDA-Approved Drugs

    The industry is still feeling the impact of the U.S. Supreme Court’s decision in  Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011). The Sorrell decision is having a significant impact on the U.S. Food and Drug Administration’s traditional ban on off-label promotion. In Sorrell, the U.S. Supreme Court affirmed that truthful, non-misleading off-label promotion of FDA-approved drugs is protected under the First Amendment. Consequently, truthful, non-misleading off-label promotion cannot be indiscriminately banned by the FDA. The decision in Sorrell will have a significant impact on how pharmaceutical companies decide to promote their FDA-approved products. No doubt, it is believed that there will be more litigation in the wake of the Sorrell decision, based on controversies about what is deemed to be truthful, non-misleading off-label promotion for individual products that have already received FDA approval. In addition to the Sorrell decision, other recent high-profile decisions are having a major impact on the pharmaceutical industry. Continue reading

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